{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,6,7]],"date-time":"2026-06-07T12:47:19Z","timestamp":1780836439974,"version":"3.54.1"},"reference-count":19,"publisher":"Wiley","issue":"6","license":[{"start":{"date-parts":[[2023,4,2]],"date-time":"2023-04-02T00:00:00Z","timestamp":1680393600000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":["accp1.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["The Journal of Clinical Pharma"],"published-print":{"date-parts":[[2023,6]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:p>Golimumab was recently evaluated in a phase 2a, randomized, double\u2010blind, placebo\u2010controlled, multicenter study (T1GER study) for safety and efficacy in children and young adults with newly diagnosed type 1 diabetes (T1D). Golimumab showed significant treatment effect where endogenous insulin production was preserved and clinical and metabolic parameters were improved. The objective of this report was to evaluate pharmacokinetic (PK) and pharmacodynamic data from the T1GER study by developing a population pharmacokinetic (PopPK) model and performing exposure\u2010response (ER) analyses. The PopPK model was developed using data from the T1D study and 2 other pediatric studies with golimumab in ulcerative colitis and in polyarticular juvenile idiopathic arthritis. A 1\u2010compartment model with first\u2010order absorption and elimination was applied to describe the concentration\u2010time profiles. Typical parameters normalized to the values in subjects with a standard weight of 70\u00a0kg were apparent clearance, 0.850\u00a0L\/day; apparent volume of distribution, 16.0\u00a0L; and absorption rate constant, 1.01\/day. From the ER analyses, no clear trends were observed for changes in both C\u2010peptide area under the concentration\u2010time curve and hemoglobin A<jats:sub>1c<\/jats:sub> levels for the relatively narrow exposure ranges following the body surface area\u2013based dosing regimen used in this study. In conclusion, the developed PopPK model was able to adequately describe the observed PK of golimumab in patients with T1D. Although golimumab showed significant treatment effect, the ER analyses did not show clear trends within the active treatment group, which may indicate that the exposure from this T1D\u2010specific dosing regimen was at the plateau of the ER curve.<\/jats:p>","DOI":"10.1002\/jcph.2217","type":"journal-article","created":{"date-parts":[[2023,3,1]],"date-time":"2023-03-01T04:24:58Z","timestamp":1677644698000},"page":"721-731","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":3,"title":["Population Pharmacokinetics and Exposure\u2010Response Modeling Analyses of Golimumab in Children and Young Adults With Recently Diagnosed Type 1 Diabetes"],"prefix":"10.1002","volume":"63","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-8404-0581","authenticated-orcid":false,"given":"Jong Bong","family":"Lee","sequence":"first","affiliation":[{"name":"Janssen Research &amp; Development  Spring House Pennsylvania USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Wangda","family":"Zhou","sequence":"additional","affiliation":[{"name":"Janssen Research &amp; Development  Spring House Pennsylvania USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Zhenhua","family":"Xu","sequence":"additional","affiliation":[{"name":"Janssen Research &amp; Development  Spring House Pennsylvania USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Joseph A.","family":"Hedrick","sequence":"additional","affiliation":[{"name":"Janssen Research &amp; Development  Raritan New Jersey USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8627-6512","authenticated-orcid":false,"given":"Jocelyn H.","family":"Leu","sequence":"additional","affiliation":[{"name":"Janssen Research &amp; Development  Spring House Pennsylvania USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2023,4,2]]},"reference":[{"key":"e_1_2_10_2_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(06)68341-4"},{"key":"e_1_2_10_3_1","doi-asserted-by":"publisher","DOI":"10.1038\/nrdp.2017.16"},{"key":"e_1_2_10_4_1","doi-asserted-by":"publisher","DOI":"10.1186\/s12889-015-1591-y"},{"key":"e_1_2_10_5_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(13)60591-7"},{"key":"e_1_2_10_6_1","doi-asserted-by":"publisher","DOI":"10.1152\/physrev.00003.2010"},{"key":"e_1_2_10_7_1","doi-asserted-by":"publisher","DOI":"10.2337\/dc14-1140"},{"key":"e_1_2_10_8_1","doi-asserted-by":"publisher","DOI":"10.1007\/s40618-017-0641-y"},{"key":"e_1_2_10_9_1","doi-asserted-by":"publisher","DOI":"10.2337\/dc09-0054"},{"key":"e_1_2_10_10_1","doi-asserted-by":"publisher","DOI":"10.4161\/mabs.1.5.9286"},{"key":"e_1_2_10_11_1","doi-asserted-by":"publisher","DOI":"10.1080\/17474124.2017.1303376"},{"key":"e_1_2_10_12_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa2006136"},{"key":"e_1_2_10_13_1","doi-asserted-by":"publisher","DOI":"10.1097\/MIB.0000000000001262"},{"key":"e_1_2_10_14_1","doi-asserted-by":"publisher","DOI":"10.1136\/annrheumdis-2016-210456"},{"key":"e_1_2_10_15_1","doi-asserted-by":"publisher","DOI":"10.1002\/jcph.1353"},{"key":"e_1_2_10_16_1","doi-asserted-by":"publisher","DOI":"10.1177\/0091270011411192"},{"key":"e_1_2_10_17_1","unstructured":"Centers for Disease Control and Prevention.CDC growth charts. 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